ID

43931

Description

Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021); ODM derived from: https://clinicaltrials.gov/show/NCT00087516

Link

https://clinicaltrials.gov/show/NCT00087516

Keywords

Versions (2)
  1. 8/30/16 8/30/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00087516

English

Eligibility Diabetes Mellitus, Type 2 NCT00087516

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes mellitus
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
patient is not pregnant or breastfeeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
male or female patient unlikely to conceive
Description

Gender Fertility Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0015895
UMLS CUI [1,3]
C0750558
patient not on an antihyperglycemic drug
Description

Hypoglycemic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0020616
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has history of type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
patient has history of ketoacidosis
Description

Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0011880
patient requires insulin within 8 weeks prior to start of study
Description

Insulin Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0686904
patient on weight loss program and is not in maintenance phase
Description

Weight Reduction Program | Maintenance Phase

Data type

boolean

Alias
UMLS CUI [1]
C3179079
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0205390
patient taking weight loss medication within 8 weeks prior to start of study
Description

Weight-Loss Agents

Data type

boolean

Alias
UMLS CUI [1]
C0376606
patient on or likely to require = 14 days or repeated courses of corticosteroids
Description

Adrenal Cortex Hormones | Adrenal Cortex Hormones Course Repeated

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C0205341
patient taking immunosuppressive/immunomodulating medication
Description

Immunosuppressive Agents | immunomodulating agent

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0005525
patient taking digoxin or other cardiac medication
Description

Digoxin | Cardiac agent

Data type

boolean

Alias
UMLS CUI [1]
C0012265
UMLS CUI [2]
C0007220
patient has undergone surgical general anesthesia within 30 days prior to start of study
Description

General Anesthesia Related Operative Surgical Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0002915
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0543467
patient taking investigational drug within 8 weeks prior to start of study
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patient is diagnosed with liver disease
Description

Liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
patient has chronic myopathy, progressive neurological/neuromuscular disorder
Description

Myopathy chronic | nervous system disorder Progressive | Neuromuscular Disease Progressive

Data type

boolean

Alias
UMLS CUI [1,1]
C0026848
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C0205329
UMLS CUI [3,1]
C0027868
UMLS CUI [3,2]
C0205329
patient has with severe cardiac conditions within the last 6 months
Description

Heart Diseases Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
patient is human immunodeficiency virus (hiv) positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
patient has hematological disorder
Description

Hematological Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018939
patient has history of malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
patient has history of alcohol or drug abuse within the past 3 years
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00087516

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
patient is not pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Fertility Unlikely
Item
male or female patient unlikely to conceive
boolean
C0079399 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
Hypoglycemic Agents
Item
patient not on an antihyperglycemic drug
boolean
C0020616 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
patient has history of type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
patient has history of ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Insulin Patient need for
Item
patient requires insulin within 8 weeks prior to start of study
boolean
C0021641 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Weight Reduction Program | Maintenance Phase
Item
patient on weight loss program and is not in maintenance phase
boolean
C3179079 (UMLS CUI [1])
C0024501 (UMLS CUI [2,1])
C0205390 (UMLS CUI [2,2])
Weight-Loss Agents
Item
patient taking weight loss medication within 8 weeks prior to start of study
boolean
C0376606 (UMLS CUI [1])
Adrenal Cortex Hormones | Adrenal Cortex Hormones Course Repeated
Item
patient on or likely to require = 14 days or repeated courses of corticosteroids
boolean
C0001617 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
Immunosuppressive Agents | immunomodulating agent
Item
patient taking immunosuppressive/immunomodulating medication
boolean
C0021081 (UMLS CUI [1])
C0005525 (UMLS CUI [2])
Digoxin | Cardiac agent
Item
patient taking digoxin or other cardiac medication
boolean
C0012265 (UMLS CUI [1])
C0007220 (UMLS CUI [2])
General Anesthesia Related Operative Surgical Procedure
Item
patient has undergone surgical general anesthesia within 30 days prior to start of study
boolean
C0002915 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Investigational New Drugs
Item
patient taking investigational drug within 8 weeks prior to start of study
boolean
C0013230 (UMLS CUI [1])
Liver disease
Item
patient is diagnosed with liver disease
boolean
C0023895 (UMLS CUI [1])
Myopathy chronic | nervous system disorder Progressive | Neuromuscular Disease Progressive
Item
patient has chronic myopathy, progressive neurological/neuromuscular disorder
boolean
C0026848 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0027765 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0027868 (UMLS CUI [3,1])
C0205329 (UMLS CUI [3,2])
Heart Diseases Severe
Item
patient has with severe cardiac conditions within the last 6 months
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
HIV Seropositivity
Item
patient is human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Hematological Disease
Item
patient has hematological disorder
boolean
C0018939 (UMLS CUI [1])
Malignant Neoplasms
Item
patient has history of malignancy
boolean
C0006826 (UMLS CUI [1])
Substance Use Disorders
Item
patient has history of alcohol or drug abuse within the past 3 years
boolean
C0038586 (UMLS CUI [1])
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